Regulatory/Legislative News

The Stellaris PC Vision Enhancement System has received 510(k) clearance from the U.S. Food and Drug Administration for the integrated 532 nm green laser and software, Bausch + Lomb announced in a press release. The laser can be upgraded for existing Stellaris systems. The system has a wireless, dual linear foot pedal with integrated laser control and improved versatility and flexibility. The pedal and foot rest reduce pitch, which improves comfort during longer procedures. An optional LIO foot pedal, cable and headset are available, the release said.

Avedro received a complete response letter from the U.S. Food and Drug Administration that identified several areas in which its new drug application for its riboflavin ophthalmic solution/KXL System needs additional information, according to a press release.

The RS-3000 Advance optical coherence tomography system has been cleared by the U.S. Food and Drug Administration, Nidek announced in a press release.

Earlier this month, doctors were hopeful that a permanent fix to the flawed sustainable growth rate formula (SGR) underlying the Medicare Physician Fee Schedule was finally on the horizon. After all, lawmakers on both sides of the aisle and in both houses agreed on a bill that would increasingly base providers’ reimbursement on certain performance measures or on a provider’s participation in alternative payment models. The momentum created by the bipartisan, bicameral agreement, however, is quickly unraveling as lawmakers debate how to pay for the $138.4 billion measure. On Friday, the House passed the SGR Repeal and Medicare Provider Payment Moderation Act of 2014 (H.R. 4015), which included an amendment from House Ways and Means Committee Chairman Dave Camp (R-Mich.) that would delay the financial penalties for people who don’t buy health insurance from 2014 to 2019.

GAITHERSBURG, Md. – The Visian toric implantable Collamer lens was recommended for approval by the Ophthalmic Devices Panel of the Medical Devices Advisory Committee of the U.S. Food and Drug Administration.

In a recently released request for information (RFI), CMS is seeking guidance from clinicians and other stakeholders about the resources and processes that will be necessary to achieve a large-scale transformation of physician practices in support of the “triple aim” of better care and better health at lower costs. Specifically, CMS is asking for information about strategies that could support “the participation of large numbers of providers in a redesigned health care system via the pathway that makes the most sense for their practices.”

In the final payment rule for fiscal year 2014, CMS codified a “Two-Midnight Rule” that applies to surgical procedures, diagnostic tests, and other treatments provided in acute care inpatient hospital facilities, long-term care hospitals, critical access hospitals, and inpatient psychiatric facilities.

Despite the winter weather emergency in Washington, the White House released President Barack Obama’s proposed budget for fiscal year 2015 on Tuesday. In its current state, the president’s proposal would spend $3.9 trillion in fiscal year 2015, leading to a budget deficit of $564 billion (a decrease from the FY2014 budget deficit of $649 billion). The Department of Health and Human Services (HHS) would have a $1 trillion budget under the president’s proposal, including $77 billion in discretionary funds for initiatives such as growing the physician work force, expanding Medicare’s value- and quality-based payment initiatives, and strengthening antifraud efforts.

On Feb. 6, the House Ways and Means, the Energy and Commerce, and the Senate Finance committees released the bipartisan, bicameral SGR Repeal and Medicare Payment Modernization Act of 2014. The negotiated bill would repeal the current SGR formula, which was adopted in 1997 to keep Medicare spending from growing faster than the economy as a whole, but over the last decade has resulted in Congress scrambling each year to avoid massive cuts in physician reimbursements.

On Jan. 31, the Office of the Inspector General published its Work Plan for Fiscal Year 2014. Each year the OIG publishes the plan, which advises the health care industry about the topics and areas on which the OIG intends to focus its resources. As usual, this year’s plan identified a number of topics of interest to ophthalmologists.